Shoreline Threaded TruProfile® Plate
FDA 510(k) K211903 · SeaSpine Orthopedics Corporation
510(k) numberK211903
Submission
- Device name
- Shoreline Threaded TruProfile® Plate
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- June 21, 2021
- Decision date
- August 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K233694 | Meridian Interbody System; WaveForm A Interbody SystemMAX · Traditional | 01/12/2024SE |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody SystemOVE · Traditional | 11/28/2023SE |
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Questions and answers
When was Shoreline Threaded TruProfile® Plate cleared by the FDA?
Shoreline Threaded TruProfile® Plate (K211903) received a 510(k) decision of Substantially Equivalent on August 30, 2021, 70 days after the submission was received.
What is the product code of K211903?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.